Toxicology Director

Our client is a rapidly growing biotechnology organization focused on advancing innovative therapies for patients with significant unmet medical needs. As they continue to expand their pipeline, they are seeking an experienced Director of Toxicology to provide strategic leadership across nonclinical safety assessment and toxicology programs.

Key Responsibilities

• Develop and lead nonclinical toxicology and safety pharmacology strategies across multiple development programs.
• Design, oversee, and interpret GLP and non-GLP toxicology studies conducted through external CRO partners.
• Provide scientific leadership for IND-enabling studies and regulatory submissions.
• Assess toxicological risks and support decision-making throughout the drug development process.
• Collaborate closely with Discovery, DMPK, Clinical Development, Regulatory Affairs, and Project Leadership teams.
• Author and review toxicology sections of regulatory documents, including INDs, IBs, briefing packages, and responses to health authorities.
• Represent toxicology and nonclinical safety during interactions with regulatory agencies.
• Manage external vendors and ensure studies are delivered on time, within budget, and to the highest scientific standards.
• Mentor and develop internal scientific staff while contributing to the growth of the nonclinical development function.

What you'll need

• PhD, DVM, PharmD, or equivalent advanced degree in Toxicology, Pharmacology, Veterinary Sciences, or a related scientific discipline.
• 10+ years of industry experience within pharmaceutical, biotechnology, or CRO environments.
• Demonstrated expertise in nonclinical toxicology and safety assessment supporting drug development programs.
• Strong knowledge of FDA, EMA, ICH, and GLP regulatory requirements.
• Experience supporting IND submissions and regulatory interactions.
• Proven ability to lead cross-functional teams and influence program strategy.